Registration Dossier

Ecotoxicological information

Short-term toxicity to aquatic invertebrates

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study, to GLP.
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Principles of method if other than guideline:
OECD-Test Guideline 202, Part I
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
no
Details on sampling:
It was agreed with the sponsor that a supporting chemical analysis for quantification of the test substance in the test solutions was not done.
Vehicle:
no
Details on test solutions:
Dilution water was prepared from four seperate stock solutions:
1. 0.22g KCl dissolved in 1L deionized water
2. 2.52g NaHCO3 dissolved in 1L deionized water
3. 11.76g CaCl2.2H2O dissolved in 1L deionized water
4. 4.93g MgSO4 .7H2O dissolved in 1L deionized water
During the preparation, 25ml each of solutions 1-4 were added to 900ml deionized water and stirred vigorously for 30min.
The test substance was introduced into the dilution water whilst stirring by the aid of a magnetic stirrer for 2 hours. The maximum concentration applied was 10g/l.
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Water flea
- Source: Laboratory bred from stock originally derived from Dr. Knie, LWA Dusseldorf
- Age at study initiation: < 24 hours
- Method of breeding: Cultivation according to SOP S 001 of Institut Fresenius Taunusstein (no details provided)
- Feeding during test: no feeding

ACCLIMATION
- Acclimation conditions (same as test or not): same as test
- Health during acclimation (any mortality observed): none
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Hardness:
See 'Details on test solutions'
Test temperature:
20±1°C
pH:
Range-finding test: 7.81-9.29
Main test: 7.53-8.07
Dissolved oxygen:
Range-finding test: initial oxygen content of 9.0 mg/l
Main test: 8.3-8.7 mg/L. Oxygen concentration did not drop below 60% of the saturation value.
Nominal and measured concentrations:
The nominal concentrations tested for the main test were 5, 10, 20, 40, 80 and 160 mg/l.
Details on test conditions:
TEST SYSTEM
- Test vessel: glass
- Type (delete if not applicable): closed
- Fill volume: 10 mL test solutions
- Aeration: No areation
- Renewal rate of test solution (frequency/flow rate): none
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4

OTHER TEST CONDITIONS
Photoperiod: 16 light :8 dark

EFFECT PARAMETERS MEASURED (with observation intervals if applicable)
Immobility after 48 hours

TEST CONCENTRATIONS
A range-range finiding study was initially performed using 10, 100, 1000 and 10000 mg of the test substance per litre of diluition water and a control. The results showed 100% immobilisation at the test concentrations of 100, 1000 and 10000 mg/l after 48 hours. Based on this information, test concentrations of 5, 10, 20, 40, 80 and 160 mg/l and a control were selected for the definitive study.

Reference substance (positive control):
yes
Remarks:
K-dichromate (tested once per month to verify the sensitivity of the Daphnia to toxic substances). The EC50 in the space of time of the experiments was 1.2 mg/l.
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
10 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: Immobility
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
28 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: Immobility
Duration:
48 h
Dose descriptor:
EC100
Effect conc.:
80 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: Immobility
Details on results:
The 48-hour EC50 value is calculated as geometric mean of all values between EC0 and EC100.
The 48-hour EC100 valus is taken from the results of the screening test.
Results with reference substance (positive control):
The EC50 in the space of time of the experiments was 1.2 mg/l.
Reported statistics and error estimates:
None

Table 1. Screening test results

immobilised daphnia (%) pH value
Conc test substance (mg/l after 24hr after 48hr at the beginning after 48hr
control (0) 0 0 8.18 7.76
10000 100 100 8.06 9.29
1000 100 100 8.14 8.38
100 50 100 8.2 8.04
10 0 20 8.21 7.81

 

Table 2. Main test results

  ratio immobilised Daphnia (%) pH value O2-Content            (mg O2/ L)  Temp°C
Conc test substance (mg/l 24hr 48hr t0 48hr t0 48hr t0 48hr
control (0) 0 0 7.69 7.53 8.7 8.6 20.5 20.5
5 0 0 7.94 7.65 8.6 8.5 20.5 20.5
10 0 0 7.79 7.67 8.4 8.5 20.5 20.5
20 0 25 7.8 7.74 8.5 8.4 20.5 20.5
40 5 70 7.82 7.79 8.5 8.3 20.5 20.5
80 10 100 7.88 7.9 8.5 8.4 20.5 20.5
160 45 100 7.96 8.07 8.5 8.3 20.5 20.5

Table 3. Calculated values

  24hr 48hr
EC0 20 mg/l 10mg/l
EC50 220mg/l 28mg/l
EC100 1000mg/l 80mg/l
Validity criteria fulfilled:
yes
Conclusions:
In an OECD guideline study, to GLP, the 48-hr EC50 of tetraammineplatinum(II) hydrogen carbonate to freshwater Daphnia magna was determined to be 28 mg/L (14.18 mg Pt/L).
Executive summary:

In an OECD guideline (TG 202) study, conducted according to GLP (Klimisch 1), the acute toxicity of tetraammineplatinum(II) hydrogen carbonate to freshwater Daphnia magna was determined in a 48-hour static test. A full test was performed in parallel with a control, with nominal test substance concentrations of 5, 10, 20, 40, 80 and 160 mg/L. The test substance did not induce immobilisation at up to 10 mg/L after 48 hours of exposure, hence the 48-hr NOEC was determined to be 10 mg/L. The 48-hr EC50 was 28 mg/L, equivalent to 14.18 mg Pt/L, and the EC100 was 80 mg/L.

Description of key information

In an OECD guideline study, to GLP, the 48-hr EC50 of tetraammineplatinum(II) hydrogen carbonate to freshwater Daphnia magna was determined to be 28 mg/L (14.18 mg Pt/L) (Lebertz, 1997).

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
14.18 mg/L

Additional information

In an OECD guideline (TG 202) study, conducted according to GLP (Klimisch 1), the acute toxicity of tetraammineplatinum(II) hydrogen carbonate to freshwater Daphnia magna was determined in a 48-hour static test. A full test was performed in parallel with a control, with nominal test substance concentrations of 5, 10, 20, 40, 80 and 160 mg/L. The test substance did not induce immobilisation at up to 10 mg/L after 48 hours of exposure, hence the 48-hr NOEC was determined to be 10 mg/L. The 48-hr EC50 was 28 mg/L, equivalent to 14.18 mg Pt/L, and the EC100 was 80 mg/L (Lebertz, 1997).